[18F]mFBG PET-CT imaging of pheochromocytoma

Phase 2

Recruiting

Conditions: Pheochromocytoma - endocrine adrenal tumor
10001353
10014710

Registration Number: NL-OMON50866

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

- The patient has provided written informed consent authorization before
participating in the study.
- The patient is >=18 years of age at the time of consent.
- The patient has a diagnosis of pheochromocytoma with a known anatomical
location or laboratory findings suspicious for pheochromocytoma defined as
elevated serum/plasma metanefrines.
- The patient should have surgery planned.
- The patient should have had a CT scan not older than 8 weeks at time of the
[18F]mFBG PET-CT..
- The patient has an ECOG status of Grade 0 - 2.

Exclusion Criteria

- Patient is mentally or legally incapacitated.
- Patient is pregnant or lactating.
- Patient has active serious infections not controlled by antibiotics.
- Patient is unable or unwilling to undergo PET-CT scanning or surgery.
- Patient did receive interfering treatment between conventional CT scanning
and [18F]mFBG PET-CT.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The number of detected pheochromocytoma lesions, proved by histology, with<br /><br>pathological [18F]mFBG uptake, defined as focal uptake above surrounding normal<br /><br>tissue, compared to number of lesions detected on protocollary conventional CT<br /><br>imaging prior to surgery.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1) Optimal time point of [18F]mFBG PET-CT imaging via comparison of SUV values<br /><br>at 1 and 2 hours on PET-CT imaging.<br /><br>2) Correlation of [18F]mFBG PET findings with pathology and<br /><br>immunohistochemistry analysis of norepinephrine transporter.<br /><br>3) Estimation of radiation dose of [18F]mFBG in normal tissues using dynamic<br /><br>PATLAK imaging<br /><br>4) Safety analysis of [18F]mFBG administration on clinical symptoms will be<br /><br>evaluated by Adverse Events outcomes</p><br>